Current through Register Vol. 40, No. 6, March 31, 2022
(a) Multiple studies have shown that opioid
addiction treatment with buprenorphine can be successfully integrated into
office practice by physicians who are not addiction specialists. In such
studies, patient outcomes are comparable to or better than outcomes of patients
treated in specialized clinics. However, as in the treatment of any medical
disorder, physicians who choose to offer addiction treatment need to understand
the nature of the underlying disorder, the specific actions of each of the
available medications (as well as any associated contraindications or
cautions), and the importance of careful patient selection and
(b) The Board has
adopted the following guidelines for the treatment of opioid addiction in
office-based settings. The guidelines are not intended to define complete
or best practice, but rather to communicate what the Board considers to be
within the boundaries of accepted professional practice.
(a) The diagnosis and medical management of
opioid addiction should be based on current knowledge and research, and should
encompass the use of both pharmacologic and nonpharmacologic treatment
modalities. Thus, before beginning to treat patients for opioid addiction, the
physician should become knowledgeable about opioid addiction and its treatment,
including the use of approved pharmacologic therapies and evidence-based
Physicians who wish to prescribe or dispense buprenorphine for the treatment of
opioid addiction must meet the requirements of DATA 2000, which are that the
physician must be licensed in the state, have a valid DEA controlled substances
registration and identification number, comply with federal and state
regulations applicable to controlled substances, and hold a current
(c) In addition to these
requirements, DATA limits the number of patients that a physician is permitted
to treat at any one time to 30 in the first year after obtaining a waiver, and
to 100 patients thereafter. The physician who wishes to treat more than 30
patients after the first year must file an application with the DEA to extend
his or her waivered capacity to do so.
(d) DATA 2000 also requires that a physician
who wishes to treat opioid addiction with buprenorphine in an office setting
must demonstrate a capacity to offer (or refer patients for) appropriate
counseling and other ancillary services, and to recognize when those services
(e) Physicians are not
permitted to delegate the prescribing of buprenorphine to non-physicians. Even
physicians who hold DEA registrations to prescribe controlled substances for
other conditions are not allowed to prescribe buprenorphine for the treatment
of addiction unless they meet the DATA requirements and hold a waiver. However,
non-physician professionals can play an active role in evaluating and
monitoring patients and providing other elements of care, in accordance with
state regulations and rules governing physician supervision and medical
consult federal regulations (
) and statutes (
); the resources
available on the DEA's website (at www.deadiversion.usdoj.gov
); and Board
rules governing the issuance of prescriptions for controlled
The objectives of the patient
assessment are to determine a given patient's eligibility for treatment, to
provide the basis for a treatment plan, and to establish a baseline measure for
use in evaluating a patient's response to treatment. Accordingly, the
assessment should be designed to achieve the following:
1. Establish the diagnosis of opiate
addiction, including the duration, pattern and severity of opioid misuse; the
patient's level of tolerance; results of previous attempts to discontinue
opioid use; past experience with agonist therapies; the nature and severity of
previous episodes of withdrawal; and the time of last opioid use and current
2. Document the
patient's use of other substances, including alcohol and other drugs of
3. Identify comorbid medical
and psychiatric conditions and disorders and determine how, when and where they
will be addressed.
4. Screen for
communicable diseases and address them as needed. Evaluate the patient's level
of physical, psychological and social functioning or impairment.
5. Assess the patient's access to social
supports, family, friends, employment, housing, finances and legal
6. Determine the
patient's readiness to participate in treatment.
(b) Assessment usually begins at the time of
the patient's first office visit and continues throughout treatment. While the
evidence is not conclusive, consensus opinion is that an initial patient
assessment is of higher quality when it includes a medical and psychiatric
history, a substance abuse history, and an evaluation of family and
psychosocial supports, as well as a pregnancy test for all women of
childbearing age. The physical examination, if performed during the initial
assessment, can be focused on evaluating neurocognitive function, identifying
sequelae of opioid addiction, and looking for evidence of severe hepatic
(c) As a general rule,
a urine drug screen or other toxicologic screen should be part of the initial
evaluation to confirm recent opioid use and to screen for unreported use of
other drugs. Ideally, this drug screen should include all opioids commonly
prescribed and/or misused in the local community, as well as illicit drugs that
are available locally. It also is advisable to access the patient's
prescription drug use history through the Alabama Department of Public Health
Prescription Drug Monitoring Program (PDMP), both to confirm compliance in
taking prescribed medications and to detect any unreported use of other
Information from family members and significant others can provide useful
additional perspectives on the patient's status, as can contact with or records
from clinicians who have treated the patient in the past.
(a) There is an emerging consensus among
addiction experts that treatment medications such as buprenorphine should be
considered as an option for every opioid-addicted patient. However, the failure
to offer medication-assisted treatment does not in itself constitute
substandard care. No single treatment is appropriate for all persons at all
times. Therefore, an individualized treatment plan is critical to the
patient's ultimate success in returning to productive functioning.
The treating physician should
balance the risks and benefits of medication-assisted treatment in general --
and treatment with buprenorphine in particular -- against the risks associated
with no treatment or treatment without medication. The various options include:
1. Simple detoxification and no other
followed by antagonist therapy;
Counseling and/or peer support without medication-assisted treatment;
4. Referral to short-term or long-term
to an OTP for methadone maintenance; or
Treatment with buprenorphine or
buprenorphine/naloxone in an office-based setting.
Patients may be suitable candidates for treatment with
buprenorphine even if past treatment episodes were not successful.
(c) If a decision is
made to offer the patient treatment with buprenorphine, the risks associated
with possible misuse and diversion are such that the combination
buprenorphine/naloxone product is preferable for most patients. The monoproduct
should be used only rarely except in pregnant women, for whom it is the
Psychosocial and other nonpharmacologic interventions often are useful
components of treatment. Such interventions typically work best in conjunction
with medication-assisted therapies; in fact, there is some evidence that the
combination of pharmacologic and non-pharmacologic interventions may be more
effective than either approach used alone. The ability to offer patients
psychosocial supports, either on-site or through referral, is a requirement of
the DATA 2000 legislation.
Educating the Patient.
(a) Every patient to whom buprenorphine is
prescribed should be cautioned to follow the directions exactly, particularly
during the induction stage. Critical issues involve when to begin dosing, the
frequency of subsequent doses, and the importance of avoiding the use of any
other illicit or prescription opioid.
(b) Concurrent use of non-opioid sedating
medications or over-the-counter products also should be discussed, and patients
should be advised to avoid the use of alcohol.
(c) Patients should be cautioned about
potential sedation or impairment of psychomotor function during the titration
phase of induction with buprenorphine.
(d) Finally, because opioids can contribute
to fatal overdoses in individuals who have lost their tolerance to opioids or
in those who are opioid-naive (such as a child or other family member), proper
and secure storage of the medication must be discussed. Particularly where
there are young people in the patient's home, the subject of safe storage and
use should be revisited periodically throughout the course of treatment, with
the discussions documented in the patient record.
(a) Although agonist medications such as
buprenorphine clearly are effective for the treatment of opioid dependence,
they do entail a substitute dependence on the prescribed medication to replace
the prior dependence on the misused opioid. This issue should be thoroughly
discussed with the patient in terms of potential risks and benefits as part of
the informed consent process. Patients and family members often are ambivalent
about agonist treatment for this reason and their concerns may influence
subsequent treatment choices. Possible topics of discussion include the
difference between addiction and physical dependence (including an explanation
of why agonist therapy is not simply "switching one addiction for another"),
the likelihood of relapse with and without medication-assisted treatment, the
projected duration of the treatment, the potential for successfully tapering
from agonist therapy at some point in the future, and the role and importance
of adjunctive therapies such as counseling and peer support. With the patient's
consent, this conversation could include family members, significant other(s),
or a guardian.
(b) A written
informed consent document, discussed with and signed by the
patient, can be helpful in reinforcing this information and establishing a set
of "ground rules." The practitioner should document the informed consent in the
patient's medical record.
(a) The terms of treatment agreements vary
widely, but typical provisions include an acknowledgment of the potential
benefits and risks of therapy and the goals of treatment; identification of one
provider and one pharmacy from whom the patient will obtain prescriptions;
authorization to communicate with all providers of care (and sometimes
significant others) and to consult the PDMP; other treatments or consultations
in which the patient is expected to participate, including recovery activities;
avoidance of illicit substances; permission for drug screens (of blood, urine,
saliva or hair/nails) and pill counts as appropriate; mechanisms for
prescription renewals, including exclusion of early renewals; expected
intervals between office visits; and specification of the conditions under
which therapy will be continued or discontinued.
(b) The agreement also should include a
statement instructing the patient to stop taking all other opioid medications
unless explicitly told to continue. Such a statement reinforces the need to
adhere to a single treatment regimen. Inclusion in the agreement of a pharmacy
address and telephone number reinforces to the patient the importance of using
one pharmacy to fill prescriptions.
(c) Finally, the treatment agreement should
set forth the objectives that will be used to evaluate treatment success, such
as freedom from intoxication, improved physical and psychosocial function, and
adherence to the treatment regimen.
(d) Copies of the treatment agreement and
informed consent should be provided to the patient and all other care
providers, and filed in the patient's medical record. The agreement should be
reviewed regularly and adjusted as needed.
Induction, Stabilization, and Follow-up.
(a) The goal of induction and stabilization
is to find the lowest dose of buprenorphine at which the patient discontinues
or markedly reduces the use of other opioids without experiencing withdrawal
symptoms, significant side effects, or uncontrollable craving for the drug of
(b) The initial induction
process requires a higher degree of attention and monitoring than the later
maintenance phase. Particular attention should be given to the timing of the
initial doses so as to minimize untoward outcomes. Withdrawal symptoms can
occur if either too much or too little buprenorphine is administered (i.e.,
spontaneous withdrawal if too little buprenorphine is given, precipitated
withdrawal if buprenorphine is administered while the opioid receptors are
substantially occupied by an opioid agonist). Undermedication or overmedication
can be avoided through a flexible approach to dosing, which sometimes requires
higher doses of treatment medication than expected, and by taking into account
stabilization phase is focused on finding the right dose for an individual
patient. A patient is stabilized when the dose allows him or her to conduct
activities of daily living and to be aware of his or her surroundings without
intoxication and without suffering withdrawal or distressing drug craving.
Although there is no precise way to determine in advance what the optimal dose
for a particular patient will be, most patients are likely to stabilize on
eight to 16 mg. of buprenorphine per day, although some may need doses of up to
24 mg per day. As the dose of Buprenorphine increases, the board recognizes
that the risk for diversion and abuse also increases. While the board
recognizes that from time to time a patient may need a higher dose of
Buprenorphine, it is expected that the clinical reasons for an increased dose
be documented in the medical records, and that the clinician utilize available
resources to be vigilant for risk of diversion regardless of dosage
(d) Buprenorphine blood
concentrations stabilize after approximately seven days of consistent dosing.
If withdrawal symptoms subsequently emerge during any 24-hour dosing interval,
the dose may be too low, or other factors may be involved. Medical factors that
may cause a patient's dose requirements to change include (but are not limited
to) starting, stopping. or changing the dose of other prescription medications;
onset and progression of pregnancy; onset of menopause; progression of liver
disease; and significant increase or decrease in weight.
(e) Dose adjustments generally can be made in
increments of 2 mg/day. Because buprenorphine has a long plasma half-life and
even longer duration of action at the mu opioid receptor, five days should be
allowed between dose adjustments.
(f) Patient adherence to medication regimens
and session appointments is associated with better treatment outcomes, and
regular monitoring can help patients plan for possible obstacles and teach them
ways to handle any problems that occur. Regular assessment of the patient's
level of engagement in treatment and the strength of the therapeutic alliance
allows for modification of the treatment plan and level of care in response to
the patient's progress or lack thereof.
(g) Early in treatment, medications should be
prescribed and follow-up visits scheduled commensurate with the patient's
demonstrated stability. Until patients have shown the ability to be compliant
with the treatment plan and responsible with their medication supplies, and
have discontinued high-risk behaviors and associated diversion risks, they
should be seen more frequently and given supplies of medication only as needed
until the next visit. As patients demonstrate stability and the risk declines,
they can be seen less often (typically once a month) and prescribed larger
supplies of medication.
monitoring during follow-up visits should address the following points:
1. Whether the patient continues to use
alcohol or illicit drugs, or to engage in non-medical use of prescription
2. The degree of compliance
with the treatment regimen, including the use of prescribed medications as
3. Changes (positive or
negative) in social functioning and relationships;
4. Avoidance of high-risk individuals,
situations, and diversion risk;
Review of whether and to what degree the patient is involved in counseling and
other psychosocial therapies, as well as in self-help activities through
participation in mutual support meetings of groups such as Narcotics
6. The presence or
absence of medication side effects; and
7. The presence or absence of medical
sequelae of substance use and its remission.
(i) The patient's compliance with regard to
use of prescribed buprenorphine and avoidance of other opioids should be
monitored through patient report, regular toxicologic analyses, reports from
significant others, and regular checks of the PDMP.
(j) Individuals being treated with
medication-assisted treatment often demonstrate dramatic improvement in
addiction-related behaviors and psychosocial functioning. Such positive changes
should be acknowledged and reinforced by the prescribing physician whenever
possible. Reducing the frequency of monitoring visits, with their associated
costs, and increasing the patient's responsibility for medications are examples
of how positive, responsible behaviors can be reinforced.
Adjusting the Treatment Plan.
(a) Treatment outcomes typically are positive
for patients who remain in treatment with medication-assisted therapies such as
buprenorphine. However, some patients struggle to discontinue their misuse of
opioids or other drugs, are inconsistent in their compliance with treatment
agreements, or succeed in achieving some therapeutic goals while not doing well
(b) Behaviors that are
not consistent with the treatment agreement should be taken seriously and used
as an opportunity to further assess the patient and adapt the treatment plan as
needed. In some cases, where the patient's behavior raises concerns about
safety or diversion of controlled medications, there may be a need to refer the
patient for treatment in a more structured environment (such as an OTP).
However, behavior that violates the treatment agreement or a relapse to
nonmedical drug use do not constitute grounds for automatic termination of
treatment. Rather, they should be taken as a signal to reassess the patient's
status, to implement changes in the treatment plan (as by intensifying the
treatment structure or intensity of services), and to document such changes in
the patient's medical record.
Whenever the best clinical course is not clear, consultation with another
practitioner may be helpful. The results of the consultation should be
discussed with the patient and any written consultation reports added to the
(d) Patients with
more serious or persistent problems may benefit from referral to a specialist
for additional evaluation and treatment. For example, the treatment of
addiction in a patient with a comorbid psychiatric disorder may be best managed
through consultation with or referral to a specialist in psychiatry or
addiction psychiatry. In other instances, aberrant or dysfunctional behaviors
may indicate the need for more vigorous engagement in peer support, counseling,
or psychotherapies, or possibly referral to a more structured treatment
and Managing Relapse.
(a) Relapse always
should be ruled out as a reason for loss of stability. Relapse to drug use has
been described as "an unfolding process in which the resumption of substance
abuse is the last event in a long series of maladaptive responses to internal
or external stressors or stimuli." It rarely is caused by any single factor;
rather, it is a dynamic process in which the patient's readiness to change
interacts with other external and internal factors. Patients in relapse vary in
the quantity and frequency of their substance use, as well as the accompanying
medical and psychosocial sequelae.
Clinical strategies to prevent and
address relapse generally encompass the following steps:
1. Identify environmental cues and stressors
that act as relapse triggers;
Help patients develop skills to cope with or manage negative emotional
3. Help the patient work
toward a more balanced lifestyle;
4. Understand and manage craving;
5. Identify and interrupt lapses and
relapses. Patients should have an emergency plan to address a lapse so that a
full-blown relapse can be avoided. If relapse does occur, be prepared to
6. Develop a
recovery support system. Families are likely to provide such support if they
are engaged in the treatment process and have an opportunity to ask questions,
share their concerns and experiences, and learn practical coping strategies and
behaviors to avoid.
It should be noted that lack of adherence to pharmacologic regimens occurs in a
substantial portion of patients being treated for addiction, with some studies
reporting that a majority of patients fail to follow the treatment plan at some
point in their care. Retention in treatment is also a problem. This is no
different from the challenges encountered in managing any chronic disease, such
as diabetes, hypertension, epilepsy, and other potentially life-threatening
disorders, and is not an indication to terminate treatment.
(d) Patients who continue to misuse opioids
after sufficient exposure to buprenorphine and ancillary psychosocial services
or who experience continued symptoms of withdrawal or craving at 32 mg of
buprenorphine should be considered for therapy with methadone.
Duration of Treatment.
(a) Available evidence does not support
routinely discontinuing medication-assisted treatment once it has been
initiated and the patient stabilized. However, this possibility frequently is
raised by patients or family members. When it is, the physician and patient
should carefully weigh the potential benefits and risks of continuing
medication-assisted treatment and determine whether buprenorphine therapy can
be safely discontinued.
indicate that opioid-dependent patients are at high risk for relapse when
medication-assisted treatment is discontinued, even after long periods of
stable maintenance. Research also shows that longer duration of treatment is
associated with better treatment outcomes. Such long-term treatment, which is
common to many medical conditions, should not be seen as treatment failure, but
rather as a cost-effective way of prolonging life and improving the quality of
life by supporting the natural and long-term process of change and recovery.
Therefore, the decision to discontinue treatment should be made only after
serious consideration of the potential consequences.
(c) As with other disease processes, the
continuation of medication-assisted treatment should be linked directly to the
patient's response (for example, his or her attainment of treatment goals).
Relapse risk is highest in the first six to 12 months after initiating
abstinence, then diminishes gradually over a period of years. Therefore, it is
reasonable to continue treatment for at least a year if the patient responds
(d) If buprenorphine is
discontinued, the patient should be tapered off the medication through use of a
safely structured regimen, and followed closely. It may be necessary to
reinstate pharmacotherapy with buprenorphine or a different medication or other
treatment services if relapse appears imminent or actually occurs. Such relapse
poses a significant risk of overdose, which should be carefully explained to
the patient. Patients also should be assured that relapse need not occur for
them to be reinstated to medication-assisted treatment.
(a) Accurate and up-to-date medical records
protect both the physician and the patient. In the event of a legal challenge,
detailed medical records that document what was done and why are essential
elements of the practitioner's defense.
(b) A written informed consent and a
treatment agreement articulating measurable treatment goals are key documents.
The treatment agreement should be updated as new information becomes available.
Both the informed consent and treatment agreement should be carefully explained
to the patient and signed by both the patient (or guardian) and the treating
physician. The medical record should clearly reflect the decision-making
process that resulted in any given treatment regimen.
(c) The patient's chart should contain a
summary of the information needed to understand the treatment plan, even
without a thorough knowledge of the patient. This includes some demographic
data, the names of other practitioners caring for the patient, all diagnoses,
therapies employed, and a list of all medications prescribed. The name,
telephone number, and address of the patient's pharmacy also should be recorded
to facilitate contact as needed.
Other documents that should be part of
the medical record, where available, include:
1. Diagnostic assessments, including the
patient history, physical examination, and any laboratory tests ordered, with
2. Actual copies of,
or references to, medical records of past hospitalizations or treatments by
3. The treatment
plan, treatment agreement, and informed consent;
4. Authorization for release of information
to other treatment providers;
Documentation of discussions with and consultation reports from other health
care providers; and
prescribed and the patient's response to them, including any adverse
(e) The medical
record also must include all prescription orders, whether written or
telephoned. In addition, written instructions for the use of all medications
should be given to the patient and documented in the record.
(f) Monitoring visits should be carefully
documented in the medical record, along with any subsequent changes to the
treatment plan. The patient's record also should contain documentation of steps
taken to prevent the diversion of treatment medications, including any
communications with other treating physicians and use of the PDMP to verify
that all prescribed medicines have been obtained and that no other
prescriptions for controlled drugs have been dispensed without the physician's
(g) Records (including
drug logs, if buprenorphine is dispensed in the office) should be up-to-date
and maintained in an accessible manner, readily available for review. Good
records demonstrate that a service was provided to the patient and establish
that the service provided was medically necessary. Even if the outcome is less
than optimal, thorough records protect the physician as well as the
Physicians who treat
patients for addiction must observe the special confidentiality requirements of
federal law found in 42 CFR, Part 2
, Confidentiality of Alcohol and Drug Abuse
Patient Records (
), which addresses the confidentiality of patients being treated for alcohol or
drug addiction. Title 42 CFR, Part 2
, includes a prohibition against release of
records or other information without the patient's consent or a valid court
order, or in cases of a bona fide medical emergency, or in the course of
mandatory reporting of child abuse.